FDA Registration Numbers Explained: FEI, DUNS, and How the FDA Identifies Foreign Facilities

Foreign food and drug manufacturers who register with the FDA encounter multiple identification numbers in the process. The DUNS number from Dun & Bradstreet comes first. The FDA Establishment Identifier — the FEI number — is issued after registration. Registration confirmation documents include both. Import documentation references both. The FDA's own public databases use both in different contexts. Understanding what each number is, where it comes from, and how the FDA uses it prevents confusion during registration and import operations.

The DUNS number: pre-registration identifier

The DUNS number — Data Universal Numbering System — is a nine-digit identifier issued by Dun & Bradstreet to identify a specific business entity at a specific location. The FDA adopted the DUNS number as the Unique Facility Identifier required in food facility registration submissions as part of the Food Safety Modernization Act implementation. Every foreign food facility must obtain a DUNS number that matches its registered legal name and physical address before submitting an FDA food facility registration. The DUNS number does not come from the FDA and is not an FDA document; it is a commercial business identifier that the FDA uses in its registration intake process. Once the facility is registered, the DUNS number remains on the registration record but the primary identifier used by the FDA going forward is the FEI number.

The FEI number: the FDA's own facility identifier

The FDA Establishment Identifier — the FEI number — is a seven-digit number assigned by the FDA to every registered facility. The FEI number is the FDA's primary internal identifier for a facility across all product categories. A facility registered for both food and drug products will have a single FEI number used in both registration systems. The FEI number appears on the registration confirmation, on Prior Notice submissions, in the FDA's facility registration database, in inspection records, and in import system lookups. It does not change when the facility updates its registration information; the FEI is assigned once and follows the facility. It is distinct from the DUNS number, which is assigned by a private company, and from the registration number, which is used in some FDA databases but is a different field from the FEI.

How the FDA uses these numbers at the border

When a food or drug shipment arrives at a US port of entry, customs and FDA personnel use the facility identifier to check the registration status of the manufacturing facility. Prior Notice submissions for food imports must include the FEI number of the manufacturing facility. If the FEI is missing or does not match a currently registered facility, the shipment may be held. Drug import entries reference the drug establishment registration and labeler code, both of which are linked to the FEI. A facility whose registration has lapsed — meaning the FEI is in the system but the registration status is inactive — cannot have products legally imported under that registration, even if the facility itself is in good physical condition.

Verification and public database access

The FDA maintains publicly searchable databases that allow importers, distributors, customs brokers, and regulators to verify facility registration status. The FDA's Food Facility Registration database can be searched by facility name, FEI number, DUNS number, or country. The FDA's drug establishment registration data is available through the FDA Drug Registration and Listing System. These databases are updated continuously as registrations are processed, renewed, or inactivated. US buyers and distributors routinely search these databases before purchasing products from foreign manufacturers to verify that the facility is currently registered and in good standing.

How FDABridge manages registration records for foreign facilities

FDABridge maintains complete registration records for foreign food and drug facilities including FEI tracking, DUNS verification, and registration status monitoring. We alert clients to status changes that could affect their ability to import products into the United States. Visit fdabridge.com/food or fdabridge.com/drug to learn about our registration services, or fdabridge.com/apply to start the process.